Counterfeit and Spurious Drugs: Big Challenges to the Health Care System Worldwide

AbstractCounterfeit drugs are one of the key challenges facing pharmaceutical supply chains and the safety of patients. Counterfeit drug is a pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. It may contain inappropriate quantities of active ingredients, may be improperly processed within the body or may contain ingredients that are not on the label, and is often sold with inaccurate, incorrect, or fake packaging and labeling. Spurious drugs are a great threat to patient’s life, the genuine pharmaceutical manufacturer and the image of the country as a whole. According to WHO, 25% of medicines consumed in poor countries could be counterfeit or below standard. An estimate suggests that these drugs are a $200 billion industry worldwide. India could be an easy target for counterfeits, as the manufacturing costs is 40% cheaper here as compared to other countries. India is fast becoming capital of counterfeit drugs, accounting for one third of the counterfeit drugs produced worldwide. It is estimated that 40 per cent of the pharma market in our country, i.e. Rs 8000 crore is under the grip of spurious and black marketed drugs. Not only is the people‘s health at stake but also there is a serious loss to the exchequer of both central and state governments as they are deprived of huge amounts on account of sales tax and excise duty. Proper drug quality monitoring, enforcement of laws and legislation, an effective and efficient regulatory environment, and awareness and vigilance on part of all stakeholders can help tackle this problem. The uses of holograms, 2D bar codes, Quick Response (QR) codes, tracers, traggants and inks, plastic tags, radio frequency identification, mass encryption technology are some other techniques to limit the counterfeiting of drugs. | | | | | | |Key word: spurious, counterfeit, substandard drug, 2D bar codes, QR codes, Holograms, Radio Frequency Identification (RFI) |

IntroductionThe Indian pharma industry has become third biggest in the world by volume and is poised to touch $20 billion mark by 2015, up from $12 billion. The domestic industry players have a major role in ensuring safety and quality and providing drugs at affordable prices.The Indian pharmaceutical companies have an extensive presence in many parts of the world, and our pharmaceutical products are known to be of good quality, safety and efficacy. Indian generic drugs have helped in bringing down the cost of treatment of various diseases worldwide, which includes HIV/AIDS1. Drugs administered to patients prove their relative safety, efficacy and improved quality before they are introduced into the markets but medicines are increasingly becoming the victim of counterfeits in recent time. Between January 1999 and October 2000 alone, 46 confidential reports relating to such drugs were received by WHO from 20 countries. The consumption of paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in antifreeze) led to 89 deaths in Haiti in 1995 and 30 infant deaths in India in 1998. A study conducted in WHO's South-East Asia Region in 2001 revealed that 38% of 104 antimalarial drugs on sale in pharmacies did not contain any active ingredients 2. Counterfeit drugs are those drugs which are sold under a product...

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